Lactated Ringer's Versus Normal Saline for Acute Pancreatitis

NCT03642769 | Completed

• 1 other identifier: APP-17-06494
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. As numerous trials have failed to show a benefit to specific pharmacologic therapies in acute pancreatitis, the mainstay of treatment has been both supportive care and early, aggressive fluid resuscitation. Small randomized studies have shown conflicting results with regards to the influence of resuscitation fluid on outcomes in acute pancreatitis, necessitating a large randomized trial to clarify if fluid choice matters or not in the treatment of acute pancreatitis. The objective of this study is to assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis. Patients presenting to the Los Angeles County Hospital with acute pancreatitis will be randomized to fluid resuscitation with NS or LR with volumes of fluid administered according to a pre-determined algorithm that will be the same for both treatment arms. The primary outcome of the study will be the change in SIRS prevalence from enrollment to 24 hours. Secondary outcomes will include the change in SIRS prevalence from enrollment to 48 hours and 72 hours, development of moderately severe or severe pancreatitis, change in PASS score, ICU admission, length of hospitalization, persistent pain or disability after discharge, and time of advancement to oral diet and discharge.

Conditions

Pancreatitis, Acute

Keywords

Pancreatitis; Fluids; SIRS; Management; Lactated Ringer; Normal Saline

Outcome Measures

Primary Outcomes (1)

• SIRS at 24 hours

  Change in SIRS prevalence from enrollment to 24 hours

  24 hours

Secondary Outcomes (12)

• SIRS at 48 hours

  48 hours

• SIRS at 72 hours

  72 hours

• Moderately severe acute pancreatitis

  48 hours

• Severe acute pancreatitis

  >48 hours

• PASS score

  24 hours

Study Arms (2)

Lactated Ringer

ACTIVE COMPARATOR

Patients will receive fluid administration of Lactated Ringer's solution at a pre-determined volume algorithm that is the same for both arms

Other: Fluid administration

Normal Saline

EXPERIMENTAL

Patients will receive fluid administration of Normal Saline solution at a pre-determined volume algorithm that is the same for both arms

Other: Fluid administration

Interventions

Fluid administration OTHER

Fluid administration of bolus and maintenance fluids

Also known as: Fluid

Lactated Ringer; Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presentation with acute pancreatitis as defined by two of three criterion; amylase or lipase \> 3x the upper limit of normal, classical abdominal pain, or imaging suggestive of pancreatitis. Such radiographic findings include swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding.

You may not qualify if:

• Patients with severe pancreatitis as defined by the Revised Atlanta Classification will be excluded. Severe pancreatitis is defined by the Revised Atlanta Classification as those with a Modified Marshall score of \>2 for their cardiovascular renal, or respiratory system will be excluded (Figure 2).13 Practically this includes patients with systolic blood pressure \<90, serum creatinine \>1.9, and PaO2/FiO2 \<300 (Figure 3). Since blood gases are unlikely to be drawn on those with mild pancreatitis we will exclude patients with an oxygen saturation \<92% on room air and certainly any patients which require intubation for respiratory failure due to pancreatitis.
• Patients who cannot tolerate increased doses of fluids for other reasons will also be excluded. This consists of those with cardiac insufficiency (CI, \>NYHA Class II heart failure), pulmonary edema, dialysis requirement, or severe liver dysfunction (albumin \< 3mg/dL, known cirrhosis).
• Pregnant women will also be excluded as they are prone to retain sodium and water, which puts them at increased risk of pulmonary congestion, ascites or peripheral edema.
• Patients who are incarcerated, younger than eighteen, or unable to give informed consent will be excluded.
• Individuals who present with clinical signs of edema or anasacra, including pulmonary congestion, peripheral swelling, and ascites, will also be ineligible for the study.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

Related Publications (17)

• Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

  PMID: 23896955 BACKGROUND

• Singh VK, Gardner TB, Papachristou GI, Rey-Riveiro M, Faghih M, Koutroumpakis E, Afghani E, Acevedo-Piedra NG, Seth N, Sinha A, Quesada-Vazquez N, Moya-Hoyo N, Sanchez-Marin C, Martinez J, Lluis F, Whitcomb DC, Zapater P, de-Madaria E. An international multicenter study of early intravenous fluid administration and outcome in acute pancreatitis. United European Gastroenterol J. 2017 Jun;5(4):491-498. doi: 10.1177/2050640616671077. Epub 2016 Sep 20.

  PMID: 28588879 BACKGROUND

• Forsmark CE, Vege SS, Wilcox CM. Acute Pancreatitis. N Engl J Med. 2016 Nov 17;375(20):1972-1981. doi: 10.1056/NEJMra1505202. No abstract available.

  PMID: 27959604 BACKGROUND

• Buxbaum JL, Quezada M, Da B, Jani N, Lane C, Mwengela D, Kelly T, Jhun P, Dhanireddy K, Laine L. Early Aggressive Hydration Hastens Clinical Improvement in Mild Acute Pancreatitis. Am J Gastroenterol. 2017 May;112(5):797-803. doi: 10.1038/ajg.2017.40. Epub 2017 Mar 7.

  PMID: 28266591 BACKGROUND

• Cuthbertson CM, Christophi C. Disturbances of the microcirculation in acute pancreatitis. Br J Surg. 2006 May;93(5):518-30. doi: 10.1002/bjs.5316.

  PMID: 16607683 BACKGROUND

• Raghunathan K, Shaw A, Nathanson B, Sturmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.

  PMID: 24674927 BACKGROUND

• Rochwerg B, Alhazzani W, Sindi A, Heels-Ansdell D, Thabane L, Fox-Robichaud A, Mbuagbaw L, Szczeklik W, Alshamsi F, Altayyar S, Ip WC, Li G, Wang M, Wludarczyk A, Zhou Q, Guyatt GH, Cook DJ, Jaeschke R, Annane D; Fluids in Sepsis and Septic Shock Group. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med. 2014 Sep 2;161(5):347-55. doi: 10.7326/M14-0178.

  PMID: 25047428 BACKGROUND

• Correa TD, Cavalcanti AB, Assuncao MS. Balanced crystalloids for septic shock resuscitation. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):463-471. doi: 10.5935/0103-507X.20160079.

  PMID: 28099643 BACKGROUND

• Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12.

  PMID: 21645639 BACKGROUND

• Lipinski M, Rydzewska-Rosolowska A, Rydzewski A, Rydzewska G. Fluid resuscitation in acute pancreatitis: Normal saline or lactated Ringer's solution? World J Gastroenterol. 2015 Aug 21;21(31):9367-72. doi: 10.3748/wjg.v21.i31.9367.

  PMID: 26309362 BACKGROUND

• de-Madaria E, Soler-Sala G, Lopez-Font I, Zapater P, Martinez J, Gomez-Escolar L, Sanchez-Fortun C, Sempere L, Perez-Lopez J, Lluis F, Perez-Mateo M. Update of the Atlanta Classification of severity of acute pancreatitis: should a moderate category be included? Pancreatology. 2010;10(5):613-9. doi: 10.1159/000308795. Epub 2010 Oct 30.

  PMID: 21042037 BACKGROUND

• Balthazar EJ. Acute pancreatitis: assessment of severity with clinical and CT evaluation. Radiology. 2002 Jun;223(3):603-13. doi: 10.1148/radiol.2233010680.

  PMID: 12034923 BACKGROUND

• Warndorf MG, Kurtzman JT, Bartel MJ, Cox M, Mackenzie T, Robinson S, Burchard PR, Gordon SR, Gardner TB. Early fluid resuscitation reduces morbidity among patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):705-9. doi: 10.1016/j.cgh.2011.03.032. Epub 2011 Apr 8.

  PMID: 21554987 BACKGROUND

• Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.

  PMID: 2070995 BACKGROUND

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• Wu BU, Batech M, Quezada M, Lew D, Fujikawa K, Kung J, Jamil LH, Chen W, Afghani E, Reicher S, Buxbaum J, Pandol SJ. Dynamic Measurement of Disease Activity in Acute Pancreatitis: The Pancreatitis Activity Scoring System. Am J Gastroenterol. 2017 Jul;112(7):1144-1152. doi: 10.1038/ajg.2017.114. Epub 2017 May 2.

  PMID: 28462914 BACKGROUND

• Buxbaum J, Quezada M, Chong B, Gupta N, Yu CY, Lane C, Da B, Leung K, Shulman I, Pandol S, Wu B. The Pancreatitis Activity Scoring System predicts clinical outcomes in acute pancreatitis: findings from a prospective cohort study. Am J Gastroenterol. 2018 May;113(5):755-764. doi: 10.1038/s41395-018-0048-1. Epub 2018 Mar 15.

  PMID: 29545634 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Hypodermoclysis; Fluid Therapy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• James Buxbaum, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: August 22, 2018
• Study Start: September 18, 2018
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

US (1)